Examples of risk assessments

The MHRA GCP Inspectorate set up a collaborative group to produce FAQs and produce example documentation relating to the risk adaptive approach. The risk assessments are not intended to be definitive templates or tools, but are provided as examples of what risk assessments may look like and organisations may use the examples to help develop their own risk assessment processes. Examples will continue to be added as they are developed for other trials.

The following risk assessment has been developed on a trial with IMP status of Type A by working with the trial research fellow on behalf of the co-sponsors, which are the Liverpool Women's NHS Foundation Trust and the University of Liverpool. MHRA would like to thank the research fellow and the trial sponsors for their assistance and support given to the collaborative group and for sharing their documentation.

This example is divided into three sections. The first, a risk assessment that would be undertaken at a trial proposal stage from governance and overall safety aspects, the second is the risk assessment of the IMP and development of a safety monitoring plan and the third is the bespoke trial risk assessment to be used to create a trial monitoring plan. It is clear how the risks of the IMP have been evaluated from the SPC and a safety monitoring plan developed that shows some adaptations from "traditional GCP" in terms of AE recording and SAE reporting, but remains in compliance with the legislation. The plan would then be reflected in the trial protocol, and reviewed and approved as part of the CTA. The bespoke risk assessment then shows how vulnerabilities have been identified (e.g. the blood sampling, consent), but also some adaptation from "traditional GCP" (e.g. IMP labelling, storage and accountability) and some areas for consideration in the development of the monitoring plan. A synopsis of the protocol is also included for reference.

The following risk assessment has been developed on a trial with IMP status of Type A by working with the trial manager from the South East Wales Trial Unit (SEWTU) on behalf of the sponsor, which is Cardiff University. MHRA would like to thank the trial manager and the trial sponsor for their assistance and support given to the collaborative group and for sharing their documentation.

This example contains a risk assessment that evaluates the IMP type and then consists of a bespoke risk assessment. It is clear how the risks of the IMP have been evaluated as no more than normal clinical practice based on the SPC. The proposed pharmacovigilance processes have been summarised and the safety monitoring plan will be in the protocol. This shows some adaptations from "traditional GCP" in terms of AE recording, but remains in compliance with the legislation. The risk assessment identifies some vulnerabilities, though not rated as "high" (e.g. consenting, privacy, inexperienced staff and use of additional fluoride), but also some adaptation from "traditional GCP" (e.g. IMP labelling, storage and accountability) and some areas for consideration in how the trial is to be monitored. A synopsis of the protocol is also included for reference.

The following risk assessment has been developed on a trial with IMP status of Type B by working with the University of Edinburgh Research Governance & QA Office*. The trial is co-sponsored by the University of Edinburgh and NHS Lothian. The MHRA would like to thank the individuals from the Research Governance & QA Office and the trial sponsors for their assistance and support given to the collaborative group and for sharing their documentation.

This example is divided into various sections:

The first section details the risks, and associated mitigations and management strategies, associated with various aspects of the planning and conduct of the trial (investigational product, study participants, study design and methods, and study organisation). The trial population is patients with paracetamol poisoning. Risks and mitigations associated with the consent process in this emergency setting are included.

Appendix 2 (Monitoring Strategy Template) outlines a range of options for monitoring (under headings of investigational product, study participants, study design and methods, and study organisation). The template is a tool that enables the focus and intensity of monitoring to be tailored on a trial-specific basis depending on the IMP status and trial-specific risks and mitigations. The “Outcome” table on pages 14-15 indicates which aspects of the monitoring strategy have been applied to this trial.